Low-Profile Intravenous Catheter Device

ABSTRACT

An intravenous catheter device and system includes: (a) a medical tubing connector at a first end of the intravenous catheter device; (b) a length of flexible, non-kinking, supported medical tubing, a first end of the non-kinking tubing being connected to a first end of the medical tubing connector; (c) an intravenous catheter portion having a first end attached to a second end of the non-kinking tubing, the non-kinking tubing extending between the intravenous catheter portion and the tubing connector; and (d) a cylindrical-shaped cuff attached to a fast outside end portion of the intravenous catheter portion, and a second outside end portion of the non-kinking tubing; wherein a central channel of the intravenous catheter portion is in fluid communication with a channel of the non-kinking, flexible tubing when the intravenous catheter device is in use. This simplified abstract is not intended to limit, and should not be interpreted as limiting, the scope of the claims.

BACKGROUND OF THE INVENTION

1. Technical Field

The present invention relates to a low-profile, non-kinking intravenouscatheter device that includes a section of flexible yet supportedintravenous tubing for conducting fluids into a patient's blood vesselor the like.

2. Background Information

Various types of intravenous (“IV”) catheters are well known in themedical field and are used throughout the world. Intravenous cathetersare used for a wide variety of applications, including hydration andadministration of intravenous fluids, medications, feeding, andtransfusions. A typical intravenous system utilizes a needle forpenetrating the skin and vein, and a catheter that remains in thepatient's blood vessel for a time once the needle is removed. A catheteris a cylindrical tube made of a thin, stiff plastic-type material. Theintravenous catheter slides over the needle into the vein once theneedle has punctured the vein. The needle is then removed, leaving theintravenous catheter in place in the vein. There are a variety of needlesafety systems in use by various catheter manufacturers, whichautomatically cover the sharp tip of the needle as it is removed fromthe catheter and discarded. The intravenous catheter is then connectedto medical tubing via a screw-type or other type of tubing connector. Asaline solution is then normally used to flush the catheter and test forproper placement of the intravenous catheter in the blood vessel.

Once placement in the patient's blood vessel has been confirmed, theintravenous catheter is secured to the patients skin with adhesive tapeuntil it is time to remove the IV, until the IV is accidentallydislodged or damaged, or until the vein blows. The latter term (“blows”)is a common term for extravasation of the intravenous fluids and/orblood into the space outside of the vein, i.e., when the seal betweenthe vein and the catheter becomes leaky and fluid being administeredthorough the catheter goes partly into the vein and partly under theskin. Unfortunately, this happens frequently because of the fact thatthe veins that are most accessible to health care professionals are theones in the patient's hand, wrist, and inner elbow (antecubital fossa),where there is much movement. The catheter of a conventional IV systemis prone to being inadvertently bumped, snagged, and hit on objectsbecause of the way the regular tubing that leads to the medical fluidsource is commonly looped. This is especially true pre- andpost-surgery, when patients often must be moved, and when theadministration of anesthetic drugs via intravenous catheters can becritical. Loss of IV access can pose very serious problems if it occursat the wrong time or with the wrong medication, for example.

Some external devices have been invented over the years that, forexample, clasp over or are strapped to an intravenous catheter, but theabove-described problems associated with the use of intravenouscatheters persist. Various other catheter-related patents andpublications relate to, for example: an instrument and method fordelivery of anesthetic drugs; a catheter with a high tensile strengthbraid wire constraint; a manipulative delivery catheter for occlusivedevices; an electrode-carrying catheter; medical tubing; and amultilayered polymeric tubing with braided layer; and methods of makingand using them and a process of making a catheter. The intravenouscatheter device of the present invention with its section of flexibleyet supported intravenous tubing is bendable into a low-profileconformation so that the present intravenous catheter device is lesslikely to kink or be dislodged from the patient's vessel.

BRIEF SUMMARY OF THE INVENTION

The present invention is a low-profile, non-kinking intravenous catheterdevice, which comprises: (a) a medical tubing connector at a first endof the intravenous catheter device; (b) a length of flexible,non-kinking, supported medical tubing, a first end of the non-kinkingtubing being connected to a first end of the medical tubing connector;(c) an intravenous catheter portion at an opposite, second end of theintravenous catheter device, a first end of the intravenous catheterportion being attached to a second end of the non-kinking tubing, thenon-kinking tubing extending between the intravenous catheter portionand the tubing connector; and preferably (d) a cylindrical shaped cuffattached to a first outside end portion of the intravenous catheterportion adjacent the first catheter portion end, and a second outsideend portion of the non-kinking tubing adjacent the second end of thenon-kinking tubing, A central channel of the intravenous catheterportion is in fluid communication with a channel of the non-kinking,flexible tubing when the intravenous catheter device is in use. Althoughthe non-kinking medical tubing is preferably wire-supported, the tubingsupport arrangement may be formed of plastic or other suitable medicalgrade material A catheter system including the intravenous catheterdevice and a needle/flash chamber unit is also included herein.

Advantages of the intravenous catheter device and system of the presentinvention include the following: 1) permits safe and comfortableinfusion of intravenous fluids into a patient; 2) permits movement ofthe patient's joints without causing kinking of the catheter tubing ordislodgement of the intravenous catheter; 3) includes a length ofnon-kinking tubing that can be bent into an appropriate shape on thepatient's body part so that the present intravenous catheter devicemaintains a low-profile against the patient's body; 4) decreases thelikelihood that a combative patient will have to be restrained becauseof concern about dislodgement of the patient's intravenous catheter; 5)significantly decreases expenses associated with kinking of cathetertubing and dislodgement of intravenous catheters, such as expensesassociated with restarting IVs, combating infections that start aroundthe catheter site, delayed surgeries, patient injuries, extendedhospital stays, and even deaths; 6) one less concern for surgical staffbefore, during, and after surgery; and 7) does not require additionalequipment or training of healthcare personnel in order to use it. Theabove advantages are particularly true of the pediatric populationbecause of their tendency to move about more than adult patients.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

A more complete understanding of the invention and its advantages willhe apparent from the following detailed description taken in conjunctionwith the accompanying drawings, wherein examples of the invention areshown, and wherein:

FIG. 1 shows a perspective view of an intravenous catheter deviceaccording to the present invention, shown on as patient's hand;

FIG. 2 is a perspective view of an intravenous catheter device accordingto the present invention, shown with adhesive tape and ready for use

FIG. 3 is a perspective view of an intravenous catheter device accordingto the present invention;

FIG. 4 is an expanded view of an intravenous catheter device accordingto the present invention;

FIG. 5 is a cross-sectional view of a cuff connector of the intravenouscatheter device of FIG. 3, taken across line 5-5;

FIG. 6 is an elevational view of an intravenous catheter deviceaccording to the present invention;

FIG. 7 is a cross-sectional view of a cuff connector of the intravenouscatheter device of FIG. 4 shown without a needle and taken across line7-7;

FIG. 8A is a cross-sectional view of the intravenous catheter deviceaccording to FIG. 4, taken across line 8-8 and shown with a mesh tubingsupport arrangement;

FIG. 8B is a cross-sectional view of the intravenous catheter deviceaccording to FIG. 4, taken across line 8-8 and shown with a spiraltubing support arrangement; and

FIG. 8C is a cross-sectional view of the intravenous catheter deviceaccording to FIG. 4, taken across line 8-8 and shown with a ring tubingsupport arrangement.

DETAILED DESCRIPTION OF THE INVENTION

In the following description, like reference characters designate likeor corresponding pans throughout the several views. Also, in thefollowing description, it is to be understood that such terms as “over,”“under,” “within,” and the like are words of convenience and are not tobe construed as limiting terms. Referring in more detail to thedrawings, a device embodying the principles and concepts of the presentinvention and generally designated by the reference numeral 10 will nowbe described.

Turning first to FIGS. 1 through 4, an intravenous catheter device 10herein comprises: (a) a medical tubing connector, preferably a leak-freescrew-type connector 19; (b) a length of flexible, non-kinking,supported medical tubing 11, a first end 14 of which is connected to afirst end 31 of the screw-on connector 19; (c) an intravenous catheterportion 12 at an opposite, second end of the intravenous catheter device10, a first end 16 of which is connected to a second end 15 of thelength of non-kinking tubing 11, the non-kinking tubing 11 extendingbetween the intravenous catheter portion 12 and the tubing connector 19;and preferably (d) a cylindrical-shaped cuff 13 connected to the firstoutside end portion 53 at the first end 16 of the intravenous catheterportion 12 and the second outside end portion 54 towards the second end15 of the non-kinking tubing 11. A preferred non-kinking tubing 11 foruse herein is wire-supported, though it does not have to bewire-supported. The tubing support arrangement may alternatively beformed of plastic or other suitable medical grade material.

The intravenous catheter device 10 preferably also includes: (e) aremovable needle 18 comprising a second, pointed end 34 for piercing thepatient's skin and blood vessel. The needle 18, which slides within theintravenous catheter portion 12 and the non kinking tubing 11, isremoved from the intravenous catheter device 10 once the second end 17of the intravenous catheter portion 12 is placed within the lumen of thepatient's vein 35. The first, non-piercing end 33 at the needle 18 ispreferably connected, to a flash chamber 27. Once the intravenouscatheter device 10 is in use, the channel 22 of the intravenous catheterportion 12 is in fluid communication with the channel 37 of thenon-kinking tubing 11. Preferably, the non-kinking tubing channel 37 isin fluid communication with the channel 38 in the medical tubing(preferably screw-on) connector 19, which is in fluid communication witha channel of the regular IV fluid tubing 43 above the screw-on connector19. The upper end of the IV fluid tubing 43 is connected to the IV bagor other source of medical fluid to he administered to the patient viathe intravenous catheter device 10.

Importantly, the flexible, non-kinking tubing 11 of the intravenouscatheter device 10 depicted in FIGS. 1, 2, and 6 permits the intravenouscatheter device 10 to remain in position on the patient once theintravenous catheter device 10 has been placed and the non-kinkingflexible tubing 11 is bent into place by the healthcare professional.The bent non-kinking tubing 11 also permits the intravenous catheterdevice 10 to maintain a low profile against the patient's limb. Thesection of non-kinking tubing 11 is not the same as the IV fluid tubing43 up above the screw-on connector 19, which leads up to the source ofthe fluid/medication to be administered to the patient through theintravenous catheter device.

Since the most easily accessed, best veins are found inside the elbowsor wrists of the majority of relatively healthy patients, an intravenouscatheter is frequently placed there. If necessary, the intravenouscatheter may also be placed on the patient's hand, thumb, ankle, scalp,belly button, foot, leg, chest, or wherever a promising site can befound on the patient's body. Unfortunately, these IV positions areuncomfortable at a minimum, and can even be dangerous if the intravenouscatheter is jostled out of place or if the medical tubing is kinkedsufficiently to inhibit flow of the medicine or other fluids passingthrough the intravenous catheter device. Even though the intravenouscatheter device 10 is likely to be placed near a patient's joint, it isnot likely to be jostled out of place, or to kink. An intravenouscatheter device 10 placed at the wrist, for example, maintains a lowprofile, even though it is taped down on the arm in a “J” or “U” shape.The catheter portion is less likely to kink or be dislodged from thepatient's vessel. A intravenous catheter device 10 placed inside theelbow (in the antecubital fossa), for example, can be taped down withoutbending it into a U-shape. The catheter device is not likely to kink orbe dislodged, because the non-kinking supported tubing 11 (rather thanthe catheter portion) flexes as the patient bonds his or her elbow andotherwise moves his or her arm. The non-kinking tubing 11 can bend andre-bend in different directions without kinking as it moves ratherfluidly with the patient's movements.

As seen in FIGS. 1 and 2, the needle 18 has been removed from theintravenous catheter device 10 prior to administration of the IV fluidsthrough the intravenous catheter device 10, and the non-kinking tubingportion 11 has been turned while maintaining a low profile. It can alsobe seen that the screw-type connector 19 has been attached to IV fluidtubing 43 for the administration of the IV fluids with or withoutmedications.

Any suitable, medical grade metal, plastic, or nylon fiber material canbe used to support the wall 24 of the non-kinking tubing 11, so long asthe support material does not compromise flexibility of the section ofnon-kinking tubing 11. For example, a length of fine, medically safewire 25 can he incorporated within the tubing material. The non-kinkingtubing 11 is preferably molded from a relatively flexible, medical gradeplastics material with a section or sections of a fine, surgical wire 25encapsulated within the plastic material in the wall of the flexibletubing. By “surgical wire” is meant that the mire 25 is suitable for usewithin the human body. By “medical grade” is meant the material cansafely be used in or on the human body. The flexible tubing materialdoes not melt at temperatures within human body temperature range(around 37 degree Centigrade).

The non-kinking tubing 11 is a smooth bore, non-compressing, flexibletubing. There are several materials that can be used, including, but notlimited to, wire-reinforced tubing, and nylon fiber tubing, Thenon-kinking tubing 11 may be supported by any suitable material thatconveys sufficient stiffness to the non-linking tubing 11 for theintravenous catheter to be pushed in and pulled out short distances,which in turn moves the catheter portion 12 under the skin, yetmaintains sufficient flexibility for the non kinking tubing 11 to bebent (into a J- or U-shape) without collapsing or kinking. Alternatetubing support arrangements within the non-kinking tubing wall 24 areseen in FIGS. 8A-C. Where the tubing material is transparent ortranslucent, the tubing support arrangement 39-41 is visible to thenaked eye. In the non-kinking tubing 11 shown in FIGS. 8A-C inparticular, the fine, surgical grade wire 25 is visible within thetransparent wall of the non-kinking tubing 11. (The non-kinking tubing11 need not be transparent, though.) The wire 25 is preferably entirelyenclosed within the plastic or other material of the non-kinking tubing11, so the wire 25 is unlikely to cause any problems reacting withfluids of the human body.

In regard to FIG. 8A, one preferred tubing arrangement is the meshsupport arrangement 39 that is also seen in cross-section FIGS. 5 and 7.A particularly preferred mesh support arrangement 39 is a fine wirescreen. The mesh extends the length of the non-kinking tubing 11 withinthe tubing wall 24. The mesh support arrangement 39 may alternatively beformed of a piece or pieces of fine plastic netting. The mesh supportstructure is believed to provide effective support for the non-kinkingtubing 11, particularly when bending the non-kinking tubing into thedesired shape after the intravenous catheter device 10 has been insertedand the needle 18 has been retracted.

A second example is the coiled, or spiral, tubing support arrangement 40shown in FIG. 8B. The particular coil arrangement depends in part uponthe properties of the wire 25 that is used. In a preferred supportarrangement, the fine wire 25 of the spiral arrangement 40 is tightlyand evenly coiled around the non-kinking tubing channel 37 within thetubing wall 24 as seen in FIG. 8B. It is believed that this tight andeven coiling arrangement keeps the non-kinking tubing channel 37 fromcollapsing when the non-kinking tubing 11 is bent, yet permits thenon-kinking tubing 11 to flex as needed. The coils extend from one endof the length of tubing to the other. The individual coils arepreferably close/adjacent to one another. A less preferred embodimentincludes loose, spaced apart spirals. A fine wire-shaped plastic supportcan be used in place of the fine wire, if desired, when the non-kinkingtubing 11 is made. The plastic spiral support arrangement 40 has thesame appearance seen in FIG. 8B. Other suitable support materials may beused in place of fine wire or plastic.

Thirdly, the ring support arrangement 41 shown in FIG. 8C is made up ofa number of wire or plastic support bands, or rings 42. The generallycylindrical-shaped support rings 42 are either adjacent one another orspaced apart from one another along the length of the non-kinking tubing11. The support rings 42 are contained within the tubing wall 24. Thus,the inside diameter of the individual support rings 42 is only slightlyless than the outside diameter of the non-kinking tubing 11. Theindividual support rings 42 are not so wide that they interfere with thecapacity of the non-kinking tubing 11 to bend into the U-shape orJ-shape when the intravenous catheter is in use. The individual supportrings 42 of FIG. 8B are same-sized, and spaced apart substantially thesame distance from one another (so that every other band in FIG. 8B is aring 42). It is believed that this even ring arrangement 41 of smallrings 42 both prevents the non-kinking tubing charnel 37 from collapsingwhen the non-kinking tubing 11 is bent, and permits the non-kinkingtubing 11 to flex as needed. The support rings 42 of the ring supportarrangement 41 may be made of plastic or metal, which have the sameappearance as shown in FIG. 8C. The support rings 42 may alternativelybe made of any other material that is found to be suitable.

The dimensions of the substantially thin, flexible tubing wall, and thediameter of the substantially uniform tubing channel within the flexibletubing 11, may vary. In general, the length of the non-kinking, flexibletubing 11 is determined by the diameter of the intravenous catheterportion 12 of the intravenous catheter device 10, as well as therelative flexibility of the non-kinking tubing 11, which isappropriately matched to the intravenous catheter portion 12.

It can be appreciated that it is difficult to maintain an open channelover time between the end of a relatively stiff, man-made catheter andthe lumen of a slippery human vein. Intravenous catheter tubing oftenbecomes entangled or is simply pulled out of the vein, particularly whenthe patient is an active child. Fluids form a dislodged catheter oftenquickly infiltrate the patient's tissue under the integument and causelocalized swelling. Sometimes simple movements by the patient orattendant cause the medical tubing to kink, which shuts off the flow offluids through the tubing to the patient's blood supply. The presentintravenous catheter device 10 helps prevent the common and sometimescritical problem of intravenous catheter entanglement, dislodgement,and/or kinking by providing a flexible, non-kinking tubing 11 betweenthe intravenous/drip catheter portion 12, which remains in the lumen ofthe patient's blood vessel 35, and the screw-type connector 19. Althoughthe non-kinking tubing 11 is in fluid connection with the intravenouscatheter portion 12, the non-kinking, flexible tubing 11 and thescrew-type connector 19 remain outside the patient's skin (not insidethe body).

The intravenous catheter device 10 is placed into the patient's vein 35using a conventional technique for inserting an intravenous catheter theskin and vein are penetrated using a sharp, specialized needle 18 andthe catheter is then introduced into the lumen of the vein 35. Finally,the needle 18 is withdrawn from the vein 35, leaving the intravenouscatheter portion 12 in place in the lumen of the vein 35. The needle 18is also called a cannula.

By “non-kinking” is meant that the flexible tubing does not kink evenwhen it is twisted into a U-shape. By “medical” is meant that theflexible tubing has been approved as safe for medical uses; fluids likeRinger's lactate solution, normal saline solution, medicines, or bloodfrom a blood bank can pass through the non-kinking, flexible tubing intothe blood stream of the patient without undue risk of blood clotting,bacterial growth, or introduction of foreign bodies, for example.

The intravenous catheter device 10 includes the intravenous catheterportion 12. The intravenous catheter 12 itself is a small, thin walled,relatively stiff medical grade plastic tube used for conducting fluids,such as medications, sugar/salt solutions, or nutrients, to a vessel ofa patient's body.

At the point of attachment between the IV catheter and the flexible,non-kinking tubing 11 is a cylindrical-shaped cuff 13, preferablyantibacterial. The purpose of the cuff is to help prevent or absorb anyleakage of blood and, importantly, to provide a substrate on which theadhesive dressing attaches. A preferred cuff 13 includes short cufffibers 26, which increase surface area. The cuff 13 is preferably madeof fibrous polyester/medical plastics. The cuff fibers 26 are preferablycoated with an antibacterial material that helps prevent bacterialgrowth at the venepuncture site 28. It is believed that the cuff fibers26 also adhere well to adhesive, tapes and film, etc., which furtherhelps to prevent the intravenous catheter device 10 from dislodging (seeFIG. 2). This is necessary because the area around a catheter site isoften wet and slick from body and/or IV fluids, which makes it difficultto adhere adhesive film to medical tubing. The fibrous cuff 13 can alsoserve to demark the end area of the non-kinking tubing 11 for the personinserting the intravenous catheter device 10 (cuff staysexternal-outside the skin). Alternatively, the intravenous catheterdevice 10 does not have a cuff. Without the cuff, the intravenouscatheter device 10 has as smooth outer surface that allows thenon-kinking tubing 11 to be partially advanced into the patient's vein35, were appropriate. Another alternative is a cuff 13 with a smooth,non-fibrous outer surface, which also allows the non-kinking tubing 11to be partially advanced into the patient's blood vessel 35 behind thecatheter portion 12 (cuff is internal-under the skin).

In the cuff 13 shown in FIG. 5, the spaced apart cuff fibers 26 projectout from the cuff band 36 relatively evenly, preferably at an angle ofbetween about 40 and about 30 degrees from the upper surface of the cuffband 36. Alternatively, the cuff fibers 26 may criss-cross one anotheras seen in FIG. 7, forming a tighter weave around the cuff band 36. Thethick weave of the criss-crossed (interwoven) cuff fibers 26 of FIG. 7is believed to soak up body and IV fluids rapidly and effectively.

In the intravenous catheter device 10 illustrated in FIGS. 8A-C, aboutone half of the cuff 13 is attached to the first end 16 of theintravenous catheter portion 12, and the other half or so of the cuff 13is attached over the second end 15 of the non-kinking tubing 11. Thefirst end 16 of the intravenous catheter portion 12 is attached to thesecond end 15 of the non-kinking, tubing 11 end-to-end, so as tomaintain a smooth bore that does not disrupt flow. The non-kinkingtubing wall underlies the relatively smooth underside of the cuff band36, as seen in FIGS. 8A-C. The underside of the cuff band 36 ispreferably adhered to the outside of the end portion of the non-kinkingtubing 11. As seen in FIGS. 8A-C, a first portion 51 of the cuff band 36is attached to an outside end portion 53 by the first end 16 of theintravenous catheter portion 12, and a second portion 52 of the cuffband 36 is attached to an outside end portion 54 by the second end 15 ofthe non-kinking tubing 11.

Alternatively but not necessarily, the second end 15 of the flexibletubing 11 overlaps, and is attached to, the first end 16 of theintravenous catheter portion 12. The first catheter portion end 16 ispreferably tapered and finished so as not to disrupt flow in the centralchannel. FIGS. 5 and 7 show cross-sections of the intravenous catheterdevice 10 across the cuff 13. In FIG. 5, the hollow needle 18, which isseen with its central channel 43, has not yet been withdrawn. As seen inFIG. 5, the outside surface of the intravenous catheter portion 12 belowthe cuff 13 contacts the inside surface of the non-kinking tubing 11 atthe ends of the intravenous catheter portion 12 and the non-kinkingtubing 11. The ends of the intravenous catheter portion 12 and thenon-kinking tubing 11, whether end-to-end or overlapped, may be adheredto one another, or not. The cuff 13 may be glued on during manufactureusing a suitable adhesive, and/or it may be press fitted.

The central channel 37 of the non-kinking tubing 11 and the channel 27of the intravenous catheter portion 12 are substantially uniform, asseen in FIG. 3, so that flow is unimpeded. The channels 22, 37 are influid communication with one another and with the lumen of the patient'sblood vessel 35 once the intravenous catheter device 10 has been placed.The blood vessel 35 may be in the patient's arm, hand, wrist, foot, leg,scalp, belly button, chest, or other site. The channels 22, 37 of theintravenous catheter portion 12 and the non-kinking tubing 11 arepreferably substantially the same in diameter.

Finally, the intravenous catheter device 10 includes as needle 18 with acentral channel 44, which is also called a cannula. Prior to use, theneedle 18 extends through the intravenous catheter portion 12,non-kinking tubing 11, screw-on connector 19, and into the flash chamber27. The needle 18 slides within the catheter device. The second end 34of the needle 18 is sufficiently pointed to pierce the patient's skinand the underlying vein 35. The non-kinking tubing 11 between theintravenous catheter portion 12 in the patient's vein 35 and thescrew-type connector 19 can be positioned and secured in a manner thatallows for movement of the patient's joints, etc., without dislodgementor kinking.

Needles 18 that are between about 0.5 and about 3.0 centimeters longerthen conventional catheter needles are preferred in the presentinvention in order to accommodate the length of non-kinking tubing 11between the intravenous catheter portion 12 and the screw-type connector19. A preferred intravenous catheter device 10 of the present inventionis between about 0.5 and about 3.0 cm longer than a conventionalintravenous catheter. The intravenous catheter portion 12 is preferablyavailable in the following sizes; 24 gauge (about 0.7 millimeters); 22gauge (about 0.9 millimeters); 20 gauge (about 1.1 millimeters); 18gauge (about 1.3 millimeters); 16 gauge (about 1.7 millimeters); and 14gauge (about 2.2 millimeters) OD (Outside Diameter).

Once the intravenous catheter device 10 has been placed, the intravenouscatheter portion 12 lies under the patient's skin within the patient'sbody at the wrist, hand, arm, leg, foot, chest, scalp, etc (“internal”).The remainder of the intravenous catheter device 10 is located outsidethe venepuncture site 28 on the patient's arm, hand, leg, foot, scalp,chest, etc. (called here “external”). As seen in FIGS. 1, 2, and 6, thenon-kinking, flexible tubing 11 is bent into a substantially curvilinearshape, preferably a U-shape or J-shape. This is done by thephlebotomist, registered nurse, or other healthcare practitioner who isin charge of placing the intravenous catheter device 10 for theparticular patient. The J-shape or the like allows the external portionof the intravenous catheter device 10 to fit neatly along the patient'slimb, etc. The non-kinking tubing 11 moves as the patient moves,continually conforming to the surface of the area of the body where itis located. The flexible tubing 11 need not be heated and cooled toforce it to retain its shape once the curvilinear shape has been formed.

As seen in FIG. 2, the intravenous catheter device 10 is preferablysecured to the patient's skin with a suitable securement membrane, pad,or film with an adhesive side, such as a transparent adhesive tape 30.The thin strip of sterile adhesive tape 30 is placed over the flexibletubing 11 adjacent to the point of insertion through the patient's skin.The adhesive tape, film, etc. may be of any suitable size or shape,depending on the particular application. The present intravenouscatheter device 10 has a much lower profile than a conventionalintravenous catheter and is much more likely to stay in place on thepatient. The intravenous catheter device 10 of the present intravenousaccess device 10 does not require complicated added instructions and caneasily be administered by healthcare practitioners.

The medical tubing connector is preferably a small screw-on/screw-offtype of tubing connector 19. The word “connector” is meant to includetubing hubs, adapters, or receivers. The intravenous catheter device 10is intended for use in conjunction with an IV bag (not shown) or asuitable medical fluid administration apparatus, such as an IV pump-typefluid dispensing machine. The purpose of the tubing connector 19 is tofacilitate attachment: 1) of the needle/flash chamber to the intravenouscatheter device 10; and, one the needle/flash chamber unit 47 has beenretracted, 2) of the male tubing connector 50/IV fluid tubing 43 thatleads up to the IV fluid administration apparatus.

As is depicted in FIGS, 1 through 4, the first end of the non-kinkingtubing 11 fits in or on, and is attached to, the first end 31 of thesmall, screw-type connector 19. As seen in FIGS. 3 and 4, the packaged,ready-for-use intravenous catheter system 20 includes the intravenouscatheter device 10, a needle/flash unit 47 and the end filter stopper21. The separate needle/flash chamber unit 47 extends through theintravenous catheter device 10 prior to and during initial placement ofthe intravenous catheter in the vein or other vessel, In theneedle/flash chamber unit 47, the first, non-piercing end 33 of theneedle 18 is attached to the first end 45 of the clear, generallycylindrical-shaped flash chamber 27. In the packaged,ready-for-placement total system 20, the needle 18 of the needle/flashchamber unit 47 extends through the non-kinking tubing 11 and theintravenous catheter portion 12, with the pointed, second end of theneedle extending out of the second end 17 of the intravenous catheterportion 12, as seen in FIG. 3. In constructing the total intravenouscatheter system 20, the needle 18 is passed through the second end 32and then the first end t of the screw connector 19, then the first end4$ of the flash chamber 27 passes through the second end 32 of the screwconnector 19 and closely fits into the hollow in the screw connector 19,as seen in FIG. 3. On the outside of the flash chamber 27, a flange 48rests against a similarly sized band on the second end 32 of the screwconnector 19 when the needle/flash unit 47 is in place.

Lastly, a male end 49 of the end filter stopper 21 is inserted into thesecond end 46 of the flash chamber 27, as illustrated in FIG. 3. Theremainder of the end filter stopper 21 seals the end of the flashchamber 27. The purpose of the transparent window in the flash chamber 2is to permit the observer to see a slight back flush of blood once thelumen of the patient's blood vessel has been hit. This confirms for thehealthcare practitioner that the lumen of the patient's vein has beenaccessed so he or she can proceed. Air can flow through the end filterstopper 21, but blood in the flash chamber 27 is prevented from flowingout (and making a mess) by the end filter stopper 21. Once the vein hasbeen punctured and its lumen has been accessed, the needle/flash chamberunit 47 and stopper 21) is retracted through the screw connector 19 endof the device, leaving the intravenous catheter portion 12, non-kinkingtubing 11, and screw connector 19 of the intravenous catheter device 10in place.

The needle/flash chamber unit 47 must be disposed of appropriately. Theneedle/flash chamber unit 47 preferably includes a conventional safetymechanism, such as one that retracts the withdrawn needle into the flashchamber or covers the piercing end of the withdrawn needle, to decreasethe odds of the needle accidentally sticking the health practitioner,relatives of the patient, maintenance workers, etc.

Thus, the intravenous catheter system 20 includes; (1) the intravenouscatheter device 10, which includes: (a) the screw-on, screw-off tubingconnector 19; (b) the flexible, non-kinking, supported medical tubing11, the first end 14 of the non-kinking tubing 11 being connected to thefirst end 31 of the screw connector 19; (e) the intravenous catheterportion 12 at the opposite, second end of the intravenous catheterdevice 10; the central channel 22 of the intravenous catheter portion 12being in fluid communication with the channel 37 of the non-kinking,flexible tubing 11 when the intravenous catheter device 10 is in use and(2) the removable tweak/flash chamber unit 47, which includes: (a) thehollow needle 18; and (b) the flash chamber 27 at the first,non-piercing end 33 of the needle 18. The needle/flash chamber unit 47is removable from the intravenous catheter device 10. The cathetersystem 20 preferably also includes; (3) the end filter stopper 21, whichis inserted in the second end 46 of the flash chamber 27. Theintravenous catheter device 10 preferably includes (d) acylindrical-shaped cuff 13 connecting a second end 15 of the non-kinkingtubing 11 to a first end 16 of the intravenous catheter portion 12.

When the catheter system 20 is assembled, the needle 18 extends throughthe central channel 22 of the intravenous catheter portion 12, and thecentral channel 37 of the non-kinking tubing 12. A portion of the needle18 preferably extends through the center of the screw connector 19. Thefirst end 45 of the flash chamber 27 closely fits into the second end 32of the screw connector 19 when the needle/flash chamber unit 47 is inthe intravenous catheter device 10. The first end 45 of the flashchamber 27 is attached to the first, non-piercing end 33 of the needle18. The flash chamber 27 is in fluid communication with the centralchannel 44 of the needle 18 when it is in use, and a portion of theneedle 18 extends through the screw connector 19 prior to retraction ofthe needle. When the intravenous catheter device 10 is in use, thecentral channel 22 of the intravenous catheter portion 12 is in fluidcommunication with the channel 37 of the non-kinking, flexible tubing11. The second, pointed end 34 of the needle 18 extends through a secondend of the intravenous catheter portion 12. The needle/flash chamberunit 47 is removed from the intravenous catheter device 10 once thesecond end 17 of the intravenous catheter portion 12 has been placedwithin the lumen of the patients blood vessel 35.

After retraction of the needle 18 but before starting the flow of fluidto the patient, a first end of a length of IV fluid tubing 43 isnormally attached to one end of a male tubing connector 50, as seen inFIGS. 1 and 2. The opposite end of the male tubing connector 50 isinserted in, press fitted, screwed onto, and/or otherwise attached tothe second end 32 of the screw connector 19. Preferably but notnecessarily, the male tubing connector 50 is inserted into a femalesecond end 32 of the screw connector 19, and then a cylindrical shapedring of the male tubing connector is screwed onto corresponding threadsof the screw connector 19. The screw-type connector 19 is preferred fora leak-free fitting. The opposite end of the IV fluid tubing 43 isconnected to the IV bag (not shown) or other delivery system for the IVfluids.

The intravenous catheter device 10 herein is not an appurtenance to acatheter nor is it a medical tubing holder. The present intravenouscatheter device 10 does not include a hinge, a bracelet, or hook andloop straps. The intravenous catheter system 20 is not an externaldevice for attachment to an existing catheter system. No externaldevice, such as a clip, clasp, cover, or protector, is required to holdthe shape of the non-kinking, flexible tubing 11. The non-kinking tubing11 is simply bent into whatever position is considered most appropriateby the healthcare professional in charge of placing the intravenouscatheter device for the particular patient. The non-kinking tubing 11between the intravenous catheter portion 12 and the tubing connector 19is flexible and not rigid. The intravenous catheter device 10 is notused in combination with other catheter devices. The non-kinking,flexible tubing 11, cuff 13, and attached intravenous catheter portion12 of the present invention may be adapted for use in delivering fluidsin other, like manner.

From the foregoing it can be realized that the described device of thepresent invention may be easily and conveniently utilized as anintravenous catheter device. It is to be understood that any dimensionsgiven herein are illustrative, and are not meant to be limiting.

While preferred embodiments of the invention have been described usingspecific terms, this description is for illustrative purposes only. Itwill be apparent to those of ordinary skill in the as that variousmodifications, substitutions, omissions, and changes may be made withoutdeparting from the spirit or scope of the invention, and that such areintended, to he within the scope of the present invention as defined bythe following claims. It is intended that the doctrine of equivalents berelied upon to determine the fair scope of these claims in connectionwith any other person's product which fall outside the literal wordingof these claims, but which in reality do not materially depart from thisinvention. Without further analysis, the foregoing will so fully revealthe gist of the present invention that others can, by applying currentknowledge, readily adapt it for various applications without omittingfeatures that, from the standpoint of prior art, fairly constituteessential characteristics of the generic or specific aspects of thisinvention.

BRIEF LIST OF REFERENCE NUMBERS USED IN THE DRAWINGS

-   10 intravenous catheter device-   11 non-kinking tubing-   12 intravenous catheter portion-   13 cuff-   14 first end of non-kinking tubing-   15 second end of non-kinking tubing-   16 first end of catheter portion-   17 second end of catheter portion-   18 needle-   19 screw connector-   20 total intravenous system-   21 end filter stopper-   22 catheter channel-   23 catheter wall-   24 non-kinking tubing wall-   25 wire-   26 cuff fibers-   27 flash chamber-   28 venepuncture site-   29 patient's skin-   30 adhesive tape-   31 first end of screw connector-   32 second end of screw connector-   33 first end of needle-   34 second, piercing end of needle-   35 patient's blood vessel-   36 cuff band-   37 non-kinking tubing channel-   38 channel of screw connector-   39 mesh support arrangement-   40 spiral support arrangement-   41 rings support arrangement-   42 support ring-   43 IV fluid tubing-   44 needle channel-   45 first end of flash chamber-   46 second end of flash chamber-   47 needle/flash chamber unit-   48 flash chamber flange-   49 male end of end filter stopper-   50 male tubing connector-   51 first portion of cuff band-   52 second portion of cuff band-   53 outside end portion of catheter portion-   54 outside end portion of non-kinking tubing

1-20. (canceled)
 21. An intravenous catheter device, comprising: amedical tubing connector, a length of tubing, and a removable needle,wherein the length of tubing comprises a flexible, non-kinking,supported portion and an intravenous catheter portion, wherein a firstend of the length of tubing proximate to the flexible, non kinking,supported portion is joined to the medical tubing connector such thatthe medical tubing connector and length of tubing each define a channelin fluid communication with one another, the removable needle configuredto pass through each channel and extend from the intravenous catheterportion.
 22. The intravenous catheter device according to claim 1,wherein the flexible, non-kinking, supported portion of the length oftubing comprises a fine wire coiled around the length of tubing.
 23. Theintravenous catheter device according to claim 2, wherein the wirecomprises metal.
 24. The intravenous catheter device according to claim2, wherein the wire comprises plastic.
 25. The intravenous catheterdevice according to claim 2, wherein the non-kinking supported tubingcomprises a ring support arrangement incorporated within a wall of thelength of tubing, the ring support arrangement being comprised of aplurality of metal support rings within the tubing wall.
 26. Theintravenous catheter device according to claim 1, wherein the catheterportion has a diameter of from about 0.7 millimeters to about 2.2millimeters.
 27. The intravenous catheter device according to claim 1,wherein the flexible, non-kinking, supported portion is configured tobend in a curvilinear shape that does not require an external device tohold open the length of tubing when bent in the curvilinear shape. 28.The intravenous catheter device according to claim 1, wherein the lengthof tubing comprises an antibacterial cuff element.
 29. The intravenouscatheter device according to claim 8, wherein the cuff element isabsorbent.
 30. A method for inserting an intravenous catheter of anintravenous catheter device, the method comprising: inserting aremovable needle from an intravenous catheter device into a patient'svein, the intravenous catheter device comprising a medical tubingconnector, a length of tubing, and a removal needle, the length oftubing comprising a flexible, non-kinking, supported portion and anintravenous catheter portion, a first end of the length of tubingproximate to the flexible, non kinking, supported portion being joinedto the medical tubing connector such that the medical tubing connectorand length of tubing each define a channel in fluid communication withone another, the removable needle passing through each channel andextending from the intravenous catheter portion as it is being insertedinto the patient's vein; inserting the intravenous catheter portion intothe patient's vein after insertion of the removable needle; withdrawingthe removable needle from the vein after insertion of the intravenouscatheter portion; bending the flexible, non-kinking, supported portionof the length of tubing after withdrawing the removable needle from thevein and securing the bent portion of the length of tubing to thepatient, wherein the bent portion of the length of tubing does notrequire an external device to hold open the length when bent in acurvilinear shape, at least a portion of the bent portion of the lengthtubing being outside of the patient's vein; and dispensing fluid intothe intravenous catheter device after insertion of the intravenouscatheter portion in the patient's vein such that the fluid travelsthrough each channel into the patient's vein.
 31. The method accordingto claim 10, wherein the flexible, non-kinking, supported portion of thelength of tubing comprises a fine wire coiled around the length oftubing.
 32. The method according to claim 10, wherein the wire comprisesmetal.
 33. The method according to claim 10, wherein the wire comprisesplastic.
 34. The method according to claim 10, wherein the catheterportion has a diameter of from about 0.7 millimeters to about 2.2millimeters.
 35. An intravenous catheter system, comprising: (1) anintravenous catheter device, the intravenous catheter device comprising:a medical tubing connector and a length of tubing, wherein the length oftubing comprises a flexible, non-kinking, supported portion and anintravenous catheter portion, wherein a first end of the length oftubing proximate to the flexible, non-kinking, supported portion isjoined to the medical tubing connector such that the medical tubingconnector and length of tubing each define a channel in fluidcommunication with one another; and (2) a removable needle/flash chamberunit, the needle/flash chamber unit comprising: (a) a hollow needle; and(b) a flash chamber at a first, non-piercing end of the needle; whereinthe needle extends through the channels of the medical tubing connectorand length of tubing, the needle/flash chamber unit being removable fromthe intravenous catheter device.
 36. The intravenous catheter systemaccording to claim 15, wherein the flexible, non-kinking, supportedportion of the length of tubing comprises a fine wire coiled around thelength of tubing.
 37. The intravenous catheter system according to claim15, further comprising an end filter stopper, a portion of which isinserted in a second end of the flash chamber; wherein a central channelof the intravenous catheter portion is in fluid communication with achannel of the length of tubing when the intravenous catheter device isin use.